A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients

Completed · Not applicable

Conditions studied: HIV Infections

In brief

To compare stavudine (d4T) and zidovudine (AZT) in slowing the progression of HIV disease. To compare the antiviral activity of d4T versus AZT as measured by plasma levels of p24 antigen and HIV viremia, and their relative efficacy by improvement and/or absence of adverse changes over time in laboratory parameters associated with HIV infection. To compare the safety of oral doses of d4T to AZT in patients with HIV infection.

Key facts

Study ID

NCT00002307

Run by

Bristol-Myers Squibb

Expected to finish

1994-12-01

Last updated by the study team

2011-08-05

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• AZT.
• Patients must have:
• Documented HIV infection as determined by a positive ELISA and/or Western blot.
• Absolute CD4 count of 100 - 500 cells/mm3 within 90 days prior to registration OR a CD4 count of 50 - 99 cells/mm3 within 30 days prior to registration.
• Prior zidovudine therapy for at least 6 months and currently tolerating at least 500 mg daily.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• Newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at time of enrollment.
• Need for chronic systemic therapy at time of enrollment.
• Intractable diarrhea.
• Signs or symptoms of bilateral peripheral neuropathy at time of screening.
• Demonstrated intolerance to zidovudine therapy.
• Any other clinical conditions that would render the patient unsuitable for study or unable to comply with the dosing requirements.
• Concurrent Medication:
• Excluded:
• Chronic systemic therapy with agents likely to suppress bone marrow, cause neurotoxicity, or create hepatic dysfunction.
• Patients with the following prior conditions are excluded:
• Prior history of bilateral peripheral neuropathy.
• Demonstrated intolerance to zidovudine therapy.
• Prior Medication:
• Excluded:
• Prior d4T, ddI, or ddC.
• Other investigational antiretroviral drugs (e.g., AZddU, Al 721, interferon, or immunomodulating drugs within 1 month prior to study entry or ribavirin within 3 months prior to study entry).
• Prior myelosuppressive, neurotoxic, or cytotoxic anticancer therapy within 3 months prior to study entry.
• Any prior therapy that would render the patient unsuitable for study or unable to comply with dosing requirements.
• Required:
• At least 6 months of prior AZT and currently tolerating at least 500 mg daily, with the last dose received no more than 7 days prior to study entry.

Where it is running

• Univ of Arizona / Health Science Ctr — Tucson, Arizona, United States
• East Bay AIDS Ctr — Berkeley, California, United States
• Children's Hosp of Los Angeles — Los Angeles, California, United States
• Combat Group — Los Angeles, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Cedars Sinai Med Ctr — Los Angeles, California, United States
• UCD Med Ctr / AIDS and Related Disorders Clinic — Sacramento, California, United States
• Children's Hosp of San Francisco — San Francisco, California, United States
• Harbor UCLA Med Ctr — Torrance, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Whitman - Walker Clinic — Washington D.C., District of Columbia, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Community Research Initiative of South Florida — Coral Gables, Florida, United States
• TheraFirst Med Ctrs Inc — Fort Lauderdale, Florida, United States
• Univ of Miami — Miami, Florida, United States
• Infectious Disease Research Institute Inc — Tampa, Florida, United States
• Dr Steven Marlowe — Atlanta, Georgia, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Infectious Diseases Research Clinic / Indiana Univ Hosp — Indianapolis, Indiana, United States
• Univ of Kansas School of Medicine / Univ Hosp — Kansas City, Kansas, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• Chase Braxton Health Service — Baltimore, Maryland, United States
• New England Deaconess Hosp — Boston, Massachusetts, United States
• Univ of Nebraska Med Ctr / HIV Clinic — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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